Method of making an introducer sheath with an inner liner

ABSTRACT

The present disclosure pertains to new methods of making an introducer sheath with an inner liner for percutaneous insertion of a medical device into a patient. The present disclosure also discloses embodiments of catheter-based prosthetic heart valves, including, prosthetic heart valves having sealing members configured to seal the interface between the prosthetic valve and the surrounding tissue of the native annulus in which the prosthetic valve is implanted.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a division of U.S. patent application Ser. No.14/561,102 filed Dec. 4, 2014 (published as US 2015/0157455), now U.S.Pat. No. 10,098,734, which claims the benefit of U.S. ProvisionalApplication No. 61/912,231, filed Dec. 5, 2013. Each of the foregoing isincorporated herein by reference.

FIELD

The present disclosure concerns embodiments of a prosthetic valve (e.g.,prosthetic heart valve) and a delivery apparatus for implanting aprosthetic valve.

BACKGROUND

Prosthetic cardiac valves have been used for many years to treat cardiacvalvular disorders. The native heart valves (such as the aortic,pulmonary and mitral valves) serve critical functions in assuring theforward flow of an adequate supply of blood through the cardiovascularsystem. These heart valves can be rendered less effective by congenital,inflammatory, or infectious conditions. Such damage to the valves canresult in serious cardiovascular compromise or death. For many years thedefinitive treatment for such disorders was the surgical repair orreplacement of the valve during open-heart surgery, but such surgeriesare prone to many complications. More recently, a transvasculartechnique has been developed for introducing and implanting a prostheticheart valve using a flexible catheter in a manner that is less invasivethan open heart surgery.

In this technique, a prosthetic valve is mounted in a crimped state onthe end portion of a flexible catheter and advanced through a bloodvessel of the patient until the prosthetic valve reaches theimplantation site. The prosthetic valve at the catheter tip is thenexpanded to its functional size at the site of the defective nativevalve, such as by inflating a balloon on which the prosthetic valve ismounted. Alternatively, the prosthetic valve can have a resilient,self-expanding stent or frame that expands the prosthetic valve to itsfunctional size when it is advanced from a delivery sheath at the distalend of the catheter.

The native valve annulus in which an expandable prosthetic valve isdeployed typically has an irregular shape mainly due to calcification.As a result, small gaps may exist between the expanded frame of theprosthetic valve and the surrounding tissue. The gaps can allow forregurgitation (leaking) of blood flowing in a direction opposite thenormal flow of blood through the valve. To minimize regurgitation,various sealing devices have been developed that seal the interfacebetween the prosthetic valve and the surrounding tissue.

SUMMARY

The present disclosure is directed to embodiments of catheter-basedprosthetic heart valves, and in particular, prosthetic heart valveshaving sealing members configured to seal the interface between theprosthetic valve and the surrounding tissue of the native annulus inwhich the prosthetic valve is implanted. The present disclosure alsodiscloses new methods of making an introducer sheath with an inner linerfor percutaneous insertion of a medical device into a patient.

In one representative embodiment, a prosthetic heart valve comprises acollapsible and expandable annular frame that is configured to becollapsed to a radially collapsed state for mounting on a deliveryapparatus and expanded to a radially expanded state inside the body. Theframe has an inflow end, an outflow end, and a longitudinal axisextending from the inflow end to the outflow end, and comprises aplurality of struts defining a plurality of rows of a plurality ofcells. The prosthetic heart valve also comprises a collapsible andexpandable valve member mounted within the annular frame, and acollapsible and expandable skirt assembly mounted within the annularframe. The skirt assembly comprises an upper skirt, a lower skirt, and asealing skirt. The upper and lower skirts prevent the sealing skirt fromcontacting the valve member and can also couple the valve member to theannular frame. When the annular frame is expanded to its radiallyexpanded state, portions of the sealing skirt protrude outwardly throughcells of the frame.

In particular embodiments, the sealing skirt is made of loop yarn. Infurther embodiments, the sealing skirt is mounted within the annularframe of the prosthetic heart valve by sutures that secure the sealingskirt and the lower skirt to the frame of the prosthetic heart valve. Inadditional embodiments, from the longitudinal axis of the prostheticheart valve, the valve member is positioned radially outward from thelower skirt, the upper skirt is positioned radially outward from thevalve member; and the sealing skirt is positioned radially outward fromthe upper skirt. In more embodiments, an outflow portion of the lowerskirt is sutured to an inflow portion of the valve member; and theinflow portion of the valve member is sutured to an inflow portion ofthe upper skirt.

In another representative embodiment, a method of making an introducersheath with an inner liner for percutaneous insertion of a medicaldevice into a patient is provided. The method comprises inserting ametal sleeve into a mold, inserting a polymer tube comprising a closedend and an open end into the metal sleeve, and pressurizing and heatingthe polymer tube to cause the polymer tube to expand against an innersurface of the metal sleeve so as to form the inner liner of the sheath.

In particular embodiments of the method, the preform cylindrical polymertube is made of nylon-12, polyethylene, or fluorinated ethylenepropylene (FEP). In further embodiments, the inner liner formed from thepolymer tube has a radial wall thickness of from about 0.025 mm (about0.001 inch) to about 0.075 mm (about 0.003 inch). In still moreembodiments, the metal sleeve has a radial wall thickness of from about0.05 mm (about 0.002 inch) to about 0.15 mm (about 0.006 inch).Pressurizing and heating the polymer tube can comprise injecting heatedcompressed gas into the polymer tube. Alternatively, pressurizing thepolymer tube can comprise injecting compressed gas into the polymer tubeand heating the polymer tube can comprise heating with a heat sourceseparate from the pressurized gas. In several embodiments, theintroducer sheath is configured for percutaneous insertion of aprosthetic heart valve through the femoral artery of the patient.

In several embodiments, the method can include forming an introducersheath with an inner liner and an outer liner for percutaneous insertionof the medical device into the patient. In some embodiments of themethod, a preform cylindrical polymer tube is used to form the outerliner. In particular embodiments, the preform cylindrical polymer tubeused to form the outer liner can be made of nylon-12, polyether blockamides, or polyethylene. In further embodiments, the outer liner has aradial wall thickness of from about 0.012 mm (about 0.0005 inch) toabout 0.075 mm (about 0.003 inch).

The foregoing and other objects, features, and advantages of theinvention will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prosthetic valve that can be used toreplace the native aortic valve of the heart, according to oneembodiment.

FIG. 2 is a perspective view of a portion of the prosthetic valve ofFIG. 1 illustrating the connection of two leaflets to the support frameof the prosthetic valve.

FIG. 3 is side elevation view of the support frame of the prostheticvalve of FIG. 1.

FIG. 4 is a perspective view of the support frame of the prostheticvalve of FIG. 1.

FIG. 5A is a cross-sectional view of the heart showing the prostheticvalve of FIG. 1 implanted within the aortic annulus.

FIG. 5B is an enlarged view of FIG. 5A illustrating the prosthetic valveimplanted within the aortic annulus, shown with the leaflet structure ofthe prosthetic valve removed for clarity.

FIG. 6 is a perspective view of the leaflet structure of the prostheticvalve of FIG. 1 shown prior to being secured to the support frame.

FIG. 7 is a cross-sectional view of the prosthetic valve of FIG. 1.

FIG. 8 is a cross-sectional view of an embodiment of a deliveryapparatus that can be used to deliver and implant a prosthetic valve,such as the prosthetic valve shown in FIG. 1.

FIGS. 8A-8C are enlarged cross-sectional views of sections of FIG. 8.

FIG. 9 is an exploded view of the delivery apparatus of FIG. 8.

FIG. 10 is a side view of the guide catheter of the delivery apparatusof FIG. 8.

FIG. 11 is a perspective, exploded view of the proximal end portion ofthe guide catheter of FIG. 10.

FIG. 12 is a perspective, exploded view of the distal end portion of theguide catheter of FIG. 10.

FIG. 13 is a side view of the torque shaft catheter of the deliveryapparatus of FIG. 8.

FIG. 14 is an enlarged side view of the rotatable screw of the torqueshaft catheter of FIG. 13.

FIG. 15 is an enlarged perspective view of a coupling member disposed atthe end of the torque shaft.

FIG. 16 is an enlarged perspective view of the threaded nut used in thetorque shaft catheter of FIG. 13.

FIG. 17 is an enlarged side view of the distal end portion of the nosecone catheter of the delivery apparatus of FIG. 8.

FIG. 17A is an enlarged, cross-sectional view of the nose cone of thecatheter shown FIG. 17.

FIG. 17B is an enlarged cross-sectional view of the distal end portionof the delivery apparatus of FIG. 8 showing the stent of a prostheticvalve retained in a compressed state within a delivery sheath.

FIG. 18 is an enlarged side view of the distal end portion of thedelivery apparatus of FIG. 8 showing the delivery sheath in a deliveryposition covering a prosthetic valve in a compressed state for deliveryinto a patient.

FIG. 19 is an enlarged cross-sectional view of a section of the distalend portion of the delivery apparatus of FIG. 8 showing thevalve-retaining mechanism securing the stent of a prosthetic valve tothe delivery apparatus.

FIG. 20 is an enlarged cross-sectional view similar to FIG. 19, showingthe inner fork of the valve-retaining mechanism in a release positionfor releasing the prosthetic valve from the delivery apparatus.

FIGS. 21 and 22 are enlarged side views of distal end portion of thedelivery apparatus of FIG. 8, illustrating the operation of the torqueshaft for deploying a prosthetic valve from a delivery sheath.

FIGS. 23-26 are various views of an embodiment of a motorized deliveryapparatus that can be used to operate the torque shaft of the deliveryapparatus shown in FIG. 8.

FIG. 27 is a perspective view of an alternative motor that can be usedto operate the torque shaft of the delivery apparatus shown in FIG. 8.

FIG. 28A is an enlarged view of a distal segment of the guide cathetershaft of FIG. 10.

FIG. 28B shows the cut pattern for forming the portion of the shaftshown in FIG. 28A, such as by laser cutting a metal tube.

FIG. 29A is an enlarged view of a distal segment of a guide cathetershaft, according to another embodiment.

FIG. 29B shows the cut pattern for forming the shaft of FIG. 29A, suchas by laser cutting a metal tube.

FIG. 30 is a perspective view of a prosthetic valve secured to the endof a delivery apparatus, according to one embodiment.

FIG. 31 is a perspective view of a prosthetic valve that can be used toreplace the native aortic valve of the heart, according to anotherembodiment.

FIG. 32 is a perspective view of the leaflet structure, also showing theskirt including an upper and lower skirt, of the prosthetic valve ofFIG. 31 shown prior to being secured to the support frame.

FIG. 33 is a cross-sectional view of the prosthetic valve of FIG. 31illustrating the configuration of the valve frame, the leaflets, theupper skirt, the lower skirt, and the sealing skirt, in one embodiment.

FIG. 34 is a diagram of the sealing skirt before attachment to the valveframe, in one embodiment.

FIG. 35 is a perspective view of a prosthetic valve including a sealingskirt that can be used to replace the native aortic valve of the heart,according to one embodiment.

FIG. 36 is a perspective view of a portion of the prosthetic valve ofFIG. 35 illustrating the sealing skirt and its connection to the supportframe of the prosthetic valve, in one embodiment.

FIG. 37 is a perspective view similar to FIG. 36 illustrating amodification of the sealing skirt.

FIG. 38 is a perspective view similar to FIG. 36 illustrating amodification of the sealing skirt.

FIG. 39 is a perspective view of a portion of the prosthetic valve ofFIG. 35 illustrating another configuration of the sealing skirt.

FIG. 40A is a perspective view of an introducer sheath, according toanother embodiment.

FIG. 40B is an enlarged, perspective view of the sleeve of theintroducer sheath of FIG. 40A.

FIG. 41 is an enlarged, perspective view of another embodiment of asleeve that can be used with the introducer sheath of FIG. 40A.

FIG. 42 is an end view of a sleeve that can be used with the introducersheath of FIG. 40A.

FIG. 43 is a perspective view of a segment of a sleeve of an introducersheath, according to another embodiment.

FIG. 44 is a side elevation view of a metal sleeve for an introducersheath, according to another embodiment.

FIG. 45 shows the cut pattern for forming the metal sleeve of FIG. 43.

FIG. 46 shows the cut pattern for forming the metal sleeve of FIG. 44.

FIG. 47 shows a cut pattern similar to FIG. 46 but having narrowerapertures.

FIGS. 48 and 49 are cross-sectional views illustrating a method ofmolding an inner liner for a metal sleeve of an introducer sheath.

DETAILED DESCRIPTION

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedescribed methods, systems, and apparatus should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The disclosed methods, systems, and apparatus are notlimited to any specific aspect, feature, or combination thereof, nor dothe disclosed methods, systems, and apparatus require that any one ormore specific advantages be present or problems be solved.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language set forthbelow. For example, operations described sequentially may in some casesbe rearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached drawings may not show the various ways in whichthe disclosed methods, systems, and apparatus can be used in conjunctionwith other systems, methods, and apparatus.

As used herein, the terms “a”, “an”, and “at least one” encompass one ormore of the specified element. That is, if two of a particular elementare present, one of these elements is also present and thus “an” elementis present. The terms “a plurality of” and “plural” mean two or more ofthe specified element.

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A”, “B”, “C”, “A and B”, “A and C”, “Band C”, or “A, B, and C”.

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

Referring first to FIG. 1, there is shown a prosthetic aortic heartvalve 10, according to one embodiment. The prosthetic valve 10 includesan expandable frame member, or stent, 12 that supports an expandablevalve member, which in the illustrated embodiment comprises a flexibleleaflet section 14. The prosthetic valve 10 is radially compressible toa compressed state for delivery through the body to a deployment siteand expandable to its functional size shown in FIG. 1 at the deploymentsite. In certain embodiments, the prosthetic valve 10 is self-expanding;that is, the prosthetic valve can radially expand to its functional sizewhen advanced from the distal end of a delivery sheath. Apparatusesparticularly suited for percutaneous delivery and implantation of aself-expanding prosthetic valve are described in detail below. In otherembodiments, the prosthetic valve can be a balloon-expandable prostheticvalve that can be adapted to be mounted in a compressed state on theballoon of a delivery catheter. The prosthetic valve can be expanded toits functional size at a deployment site by inflating the balloon, asknown in the art.

The illustrated prosthetic valve 10 is adapted to be deployed in thenative aortic annulus, although it also can be used to replace the othernative valves of the heart (the mitral, tricuspid, and pulmonaryvalves). Moreover, the prosthetic valve 10 can be adapted to replaceother valves within the body, such venous valves.

FIGS. 3 and 4 show the stent 12 without the leaflet section 14 forpurposes of illustration. As shown, the stent 12 can be formed from aplurality of longitudinally extending, generally sinusoidal-shaped framemembers, or struts, 16. The struts 16 are formed with alternating bendsand are welded or otherwise secured to each other at nodes 18 formedfrom the vertices of adjacent bends so as to form a mesh structure. Thestruts 16 can be made of a suitable shape memory material, such as thenickel titanium alloy known as Nitinol, that allows the prosthetic valveto be compressed to a reduced diameter for delivery in a deliveryapparatus (such as described below) and then causes the prosthetic valveto expand to its functional size inside the patient's body when deployedfrom the delivery apparatus. If the prosthetic valve is aballoon-expandable prosthetic valve that is adapted to be crimped ontoan inflatable balloon of a delivery apparatus and expanded to itsfunctional size by inflation of the balloon, the stent 12 can be made ofa suitable ductile material, such as stainless steel.

The stent 12 has an inflow end 26 and an outflow end 27. The meshstructure formed by struts 16 comprises a generally cylindrical “upper”or outflow end portion 20, an outwardly bowed or distended intermediatesection 22, and an inwardly bowed “lower” or inflow end portion 24. Theintermediate section 22 desirably is sized and shaped to extend into thesinuses of Valsalva in the aortic root to assist in anchoring theprosthetic valve in place once implanted. As shown, the mesh structuredesirably has a curved shape along its entire length that graduallyincreases in diameter from the outflow end portion 20 to theintermediate section 22, then gradually decreases in diameter from theintermediate section 22 to a location on the inflow end portion 24, andthen gradually increases in diameter to form a flared portionterminating at the inflow end 26.

When the prosthetic valve is in its expanded state, the intermediatesection 22 has a diameter D₁, the inflow end portion lower section 24has a minimum diameter D₂, the inflow end 26 has a diameter D₃, and theoutflow end portion 20 has a diameter D₄, where D₂ is less than D₁ andD₃, and D₄ is less than D₂. In addition, D₁ and D₃ desirably are greaterthan the diameter of the native annulus in which the prosthetic valve isto be implanted. In this manner, the overall shape of the stent 12assists in retaining the prosthetic valve at the implantation site. Morespecifically, and referring to FIGS. 5A and 5B, the prosthetic valve 10can be implanted within a native valve (the aortic valve in theillustrated example) such that the lower section 24 is positioned withinthe aortic annulus 28, the intermediate section 22 extends above theaortic annulus into the sinuses of Valsalva 56, and the lower flared end26 extends below the aortic annulus. The prosthetic valve 10 is retainedwithin the native valve by the radial outward force of the lower section24 against the surrounding tissue of the aortic annulus 28 as well asthe geometry of the stent. Specifically, the intermediate section 22 andthe flared lower end 26 extend radially outwardly beyond the aorticannulus 28 to better resist against axial dislodgement of the prostheticvalve in the downstream and upstream directions (toward and away fromthe aorta). Depending on the condition of the native leaflets 58, theprosthetic valve typically is deployed within the native annulus 28 withthe native leaflets 58 folded upwardly and compressed between the outersurface of the stent 12 and the walls of the sinuses of Valsalva 56, asdepicted in FIG. 5B. In some cases, it may be desirable to excise theleaflets 58 prior to implanting the prosthetic valve 10.

Known prosthetic valves having a self-expanding frame typically haveadditional anchoring devices or frame portions that extend into andbecome fixed to non-diseased areas of the vasculature. Because the shapeof the stent 12 assists in retaining the prosthetic valve, additionalanchoring devices are not required and the overall length L of the stentcan be minimized to prevent the stent upper portion 20 from extendinginto the non-diseased area of the aorta, or to at least minimize theextent to which the upper portion 20 extends into the non-diseased areaof the aorta. Avoiding the non-diseased area of the patient'svasculature helps avoid complications if future intervention isrequired. For example, the prosthetic valve can be more easily removedfrom the patient because the stent is primarily anchored to the diseasedpart of the native valve. Furthermore, a shorter prosthetic valve ismore easily navigated around the aortic arch.

In particular embodiments, for a prosthetic valve intended for use in a22-mm to 24-mm annulus, the diameter D1 is from about 28 mm to about 32mm, with about 30 mm being a specific example; the diameter D2 is fromabout 24 mm to about 28 mm, with about 26 mm being a specific example;the diameter D3 is from about 28 mm to about 32 mm, with about 30 mmbeing a specific example; and the diameter D4 is from about 24 mm toabout 28 mm, with about 26 mm being a specific example. The length L inparticular embodiments is from about 20 mm to about 24 mm, with about 22mm being a specific example.

Referring to FIG. 1, the stent 12 can have a plurality of angularlyspaced retaining arms, or projections, in the form of posts 30 (three inthe illustrated embodiment) that extend from the stent upper portion 20.Each retaining arm 30 has a respective aperture 32 that is sized toreceive prongs of a valve-retaining mechanism that can be used to form areleasable connection between the prosthetic valve and a deliveryapparatus (described below). In alternative embodiments, the retainingarms 30 need not be provided if a valve-retaining mechanism is not used.

As best shown in FIGS. 6 and 7, the leaflet assembly 14 in theillustrated embodiment comprises three leaflets 34 a, 34 b, 34 c made ofa flexible material. Each leaflet has an inflow end portion 60 and anoutflow end portion 62. The leaflets can comprise any suitablebiological material (e.g., pericardial tissue, such as bovine or equinepericardium), bio-compatible synthetic materials, or other suchmaterials, such as those described in U.S. Pat. No. 6,730,118, which isincorporated herein by reference. The leaflet assembly 14 can include anannular reinforcing skirt 42 that is secured to the inflow end portionsof the leaflets 34 a, 34 b, 34 c at a suture line 44 adjacent the inflowend of the prosthetic valve. The inflow end portion of the leafletassembly 14 can be secured to the stent 12 by suturing the skirt 42 tostruts 16 of the lower section 24 of the stent (best shown in FIG. 1).As shown in FIG. 7, the leaflet assembly 14 can further include an innerreinforcing strip 46 that is secured to the inner surfaces of the inflowend portions 60 of the leaflets.

Referring to FIGS. 1 and 2, the outflow end portion of the leafletassembly 14 can be secured to the upper portion of the stent 12 at threeangularly spaced commissure attachments of the leaflets 34 a, 34 b, and34 c. As best shown in FIG. 2, each commissure attachment can be formedby wrapping a reinforcing section 36 around adjacent upper edge portions38 of a pair of leaflets at the commissure formed by the two leafletsand securing the reinforcing section 36 to the edge portions 38 withsutures 48. The sandwiched layers of the reinforcing material andleaflets can then be secured to the struts 16 of the stent 12 withsutures 50 adjacent the outflow end of the stent. The leaflets thereforedesirably extend the entire length or substantially the entire length ofthe stent from the inflow end 26 to the outflow end 27. The reinforcingsections 36 reinforces the attachment of the leaflets to the stent so asto minimize stress concentrations at the suture lines and avoid “needleholes” on the portions of the leaflets that flex during use. Thereinforcing sections 36, the skirt 42, and the inner reinforcing strip46 (FIG. 7) desirably are made of a bio-compatible synthetic material,such as polytetrafluoroethylene (PTFE), or a woven fabric material, suchas woven polyester (e.g., polyethylene terephthalate) (PET), DACRON®).

FIG. 7 shows the operation of the prosthetic valve 10. During diastole,the leaflets 34 a, 34 b, 34 c collapse to effectively close theprosthetic valve. As shown, the curved shape of the intermediate section22 of the stent 12 defines a space between the intermediate section andthe leaflets that mimics the sinuses of Valsalva. Thus, when theleaflets close, backflow entering the “sinuses” creates a turbulent flowof blood along the upper surfaces of the leaflets, as indicated byarrows 52. This turbulence assists in washing the leaflets and the skirt42 to minimize or reduce clot formation.

The prosthetic valve 10 can be implanted in a retrograde approach wherethe prosthetic valve, mounted in a crimped state at the distal end of adelivery apparatus, is introduced into the body via the femoral arteryand advanced through the aortic arch to the heart, as further describedin U.S. Patent Application Publication No. 2008/0065011, which isincorporated herein by reference.

FIGS. 8 and 9 show a delivery apparatus 100, according to oneembodiment, that can be used to deliver a self-expanding prostheticvalve, such as prosthetic valve 10 described above, through a patient'svasculature. The delivery apparatus 100 comprises a first, outermost ormain catheter 102 (shown alone in FIG. 10) having an elongated shaft104, the distal end of which is coupled to a delivery sheath 106 (FIG.18; also referred to as a delivery cylinder). The proximal end of themain catheter 102 is connected to a handle of the delivery apparatus.FIGS. 23-26 show an embodiment of a handle mechanism having an electricmotor for operating the delivery apparatus. The handle mechanism isdescribed in detail below. During delivery of a prosthetic valve, thehandle can be used by a surgeon to advance and retract the deliveryapparatus through the patient's vasculature. Although not required, themain catheter 102 can comprise a guide catheter that is configured toallow a surgeon to guide or control the amount the bending or flexing ofa distal portion of the shaft 104 as it is advanced through thepatient's vasculature, such as further described below. Anotherembodiment of a guide catheter is disclosed in U.S. Patent ApplicationPublication No. 2008/0065011, which is incorporated herein by reference.

As best shown in FIG. 9, the delivery apparatus 100 also includes asecond, intermediate catheter 108 (also referred to herein as a torqueshaft catheter) having an elongated shaft 110 (also referred to hereinas a torque shaft) and an elongated screw 112 connected to the distalend of the shaft 110. The shaft 110 of the intermediate catheter 108extends coaxially through the shaft 104 of the main catheter 102. Thedelivery apparatus 100 can also include a third, nose-cone catheter 118having an elongated shaft 120 and a nose piece, or nose cone, 122secured to the distal end portion of the shaft 120. The nose piece 122can have a tapered outer surface as shown for atraumatic trackingthrough the patient's vasculature. The shaft 120 of the nose-conecatheter extends through the prosthetic valve 10 (not shown in FIGS.8-9) and the shaft 110 of the intermediate catheter 108. In theillustrated configuration, the innermost shaft 120 is configured to bemoveable axially and rotatably relative to the shafts 104, 110, and thetorque shaft 110 is configured to be rotatable relative to the shafts104, 120 to effect valve deployment and release of the prosthetic valvefrom the delivery apparatus, as described in detail below. Additionally,the innermost shaft 120 can have a lumen for receiving a guide wire sothat the delivery apparatus can be advanced over the guide wire insidethe patient's vasculature.

As best shown in FIG. 10, the outer catheter 102 can comprise a flexcontrol mechanism 168 at a proximal end thereof to control the amountthe bending or flexing of a distal portion of the outer shaft 104 as itis advanced through the patient's vasculature, such as further describedbelow. The outer shaft 104 can comprise a proximal segment 166 thatextends from the flex control mechanism 168 and a distal segment 126that comprises a slotted metal tube that increases the flexibility ofthe outer shaft at this location. The distal end portion of the distalsegment 126 can comprises an outer fork 130 of a valve-retainingmechanism 114 (FIGS. 8 and 8B) that is configured to releasably secure aprosthetic valve 10 to the delivery apparatus 100 during valve delivery,as described in detail below.

FIG. 28A is an enlarged view of a portion of the distal segment 126 ofthe outer shaft 104. FIG. 28B shows the cut pattern that can be used toform the distal segment 126 by laser cutting the pattern in a metaltube. The distal segment 126 comprises a plurality of interconnectedcircular bands or links 160 forming a slotted metal tube. A pull wire162 can be positioned inside the distal segment 126 and can extend froma location 164 of the distal segment 126 (FIGS. 10 and 12) to the flexcontrol mechanism. The distal end of the pull wire 162 can be secured tothe inner surface of the distal segment 126 at location 164, such as bywelding. The proximal end of the pull wire 162 can be operativelyconnected to the flex control mechanism 168, which is configured toapply and release tension to the pull wire in order to control bendingof the shaft, as further described below. The links 160 of the shaft andthe gaps between adjacent links are shaped to allow bending of the shaftupon application of light pulling force on the pull wire 162. In theillustrated embodiment, as best shown in FIG. 12, the distal segment 126is secured to a proximal segment 166 having a different construction(e.g., one or more layers of polymeric tubing). In the illustratedembodiment, the proximal segment 166 extends from the flex controlmechanism 168 to the distal segment 126 and therefore makes up themajority of the length of the outer shaft 104. In alternativeembodiments, the entire length or substantially the entire length of theouter shaft 104 can be formed from a slotted metal tube comprising oneor more sections of interconnected links 160. In any case, the use of amain shaft having such a construction can allow the delivery apparatusto be highly steerable.

The width of the links 160 can be varied to vary the flexibility of thedistal segment along its length. For example, the links within thedistal end portion of the slotted tube can be relatively narrower toincrease the flexibility of the shaft at that location while the linkswithin the proximal end portion of the slotted tube can be relativelywider so that the shaft is relatively less flexible at that location.

FIG. 29A shows an alternative embodiment of a distal segment, indicatedat 126′, which can be formed, for example, by laser cutting a metaltube. The segment 126′ can comprise the distal segment of an outer shaftof a delivery apparatus (as shown in FIG. 12) or substantially theentire length of an outer shaft can have the construction shown in FIG.29A. FIG. 29B shows the cut pattern for forming the segment 126′. Inanother embodiment, a delivery apparatus can include a composite outershaft comprising a laser-cut metal tube laminated with a polymeric outerlayer that is fused within the gaps in the metal layer. In one example,a composite shaft can comprise a laser cut metal tube having the cutpattern of FIGS. 29A and 29B and a polymeric outer layer fused in thegaps between the links 160 of the metal tube. In another example, acomposite shaft can comprise a laser cut metal tube having the cutpattern of FIGS. 28A and 28B and a polymeric outer layer fused in thegaps between the links 160 of the metal tube. A composite shaft also caninclude a polymeric inner layer fused in the gaps between the links 160of the metal tube.

Referring to FIGS. 8A and 11, the flex control mechanism 168 cancomprise a rotatable housing, or handle portion, 186 that houses a slidenut 188 mounted on a rail 192. The slide nut 188 is prevented fromrotating within the housing by one or more rods 192, each of which ispartially disposed in a corresponding recess within the rail 192 and aslot or recess on the inside of the nut 188. The proximal end of thepull wire 162 is secured to the nut 188. The nut 188 has externalthreads that engage internal threads of the housing. Thus, rotating thehousing 186 causes the nut 188 to move axially within the housing in theproximal or distal direction, depending on the direction of rotation ofthe housing. Rotating the housing in a first direction (e.g.,clockwise), causes the nut to travel in the proximal direction, whichapplies tension to the pull wire 162, which causes the distal end of thedelivery apparatus to bend or flex. Rotating the housing in a seconddirection (e.g., counterclockwise), causes the nut to travel in thedistal direction, which relieves tension in the pull wire 162 and allowsthe distal end of the delivery apparatus to flex back to its pre-flexedconfiguration under its own resiliency.

As best shown in FIG. 13, the torque shaft catheter 108 includes anannular projection in the form of a ring 128 (also referred to as ananchoring disc) mounted on the distal end portion of the torque shaft110 adjacent the screw 112. The ring 128 is secured to the outer surfaceof the torque shaft 110 such that it cannot move axially or rotationallyrelative to the torque shaft. The inner surface of the outer shaft 104is formed with a feature, such as a slot or recess, that receives thering 128 in such a manner that the ring and the corresponding feature onthe inner surface of the outer shaft 104 allow the torque shaft 110 torotate relative to the outer shaft 104 but prevent the torque shaft frommoving axially relative to the outer shaft. The corresponding feature onthe outer shaft 104 that receives the ring 128 can be inwardly extendingtab portions formed in the distal segment 126, such as shown at 164 inFIG. 12. In the illustrated embodiment (as best shown in FIG. 14), thering 128 is an integral part of the screw 112 (i.e., the screw 112 andthe ring 128 are portions of single component). Alternatively, the screw112 and the ring are separately formed components but are both fixedlysecured to the distal end of the torque shaft 110.

The torque shaft 110 desirably is configured to be rotatable relative tothe delivery sheath 106 to effect incremental and controlled advancementof the prosthetic valve 10 from the delivery sheath 106. To such ends,and according to one embodiment, the delivery apparatus 100 can includea sheath retaining ring in the form of a threaded nut 150 mounted on theexternal threads of the screw 112. As best shown in FIG. 16, the nut 150includes internal threads 152 that engage the external threads of thescrew and axially extending legs 154. Each leg 154 has a raised distalend portion that extends into and/or forms a snap fit connection withopenings 172 in the proximal end of the sheath 106 (as best shown inFIG. 18) so as to secure the sheath 106 to the nut 150. As illustratedin FIGS. 17B and 18, the sheath 106 extends over the prosthetic valve 10and retains the prosthetic valve in a radially compressed state untilthe sheath 106 is retracted by the user to deploy the prosthetic valve.

As best shown in FIGS. 21 and 22, the outer fork 130 of thevalve-retaining mechanism comprises a plurality of prongs 134, each ofwhich extends through a region defined between two adjacent legs 154 ofthe nut so as to prevent rotation of the nut relative to the screw 112upon rotation of the screw. As such, rotation of the torque shaft 110(and thus the screw 112) causes corresponding axial movement of the nut150. The connection between the nut 150 and the sheath 106 is configuredsuch that axially movement of the nut along the screw 112 (in the distalor proximal direction) causes the sheath 106 to move axially in the samedirection relative to the screw and the valve-retaining mechanism. FIG.21 shows the nut 150 in a distal position wherein the sheath 106 (notshown in FIG. 21) extends over and retains the prosthetic valve 10 in acompressed state for delivery. Movement of the nut 150 from the distalposition (FIG. 21) to a proximal position (FIG. 22) causes the sheath106 to move in the proximal direction, thereby deploying the prostheticvalve from the sheath 106. Rotation of the torque shaft 110 to effectaxial movement of the sheath 106 can be accomplished with a motorizedmechanism or by manually turning a crank or wheel (e.g., as described inU.S. Patent Application Publication No. 2012/0239142, which isincorporated by reference herein in its entirety).

FIG. 17 shows an enlarged view of the nose cone 122 secured to thedistal end of the innermost shaft 120. The nose cone 122 in theillustrated embodiment includes a proximal end portion 174 that is sizedto fit inside the distal end of the sheath 106. An intermediate section176 of the nose cone is positioned immediately adjacent the end of thesheath in use and is formed with a plurality of longitudinal grooves orrecessed portions 178. The diameter of the intermediate section 176 atits proximal end 180 desirably is slightly larger than the outerdiameter of the sheath 106. The proximal end 180 can be held in closecontact with the distal end of the sheath 106 to protect surroundingtissue from coming into contact with the metal edge of the sheath. Thegrooves 178 allow the intermediate section to be compressed radially asthe delivery apparatus is advanced through an introducer sheath. Thisallows the nose cone 122 to be slightly oversized relative to the innerdiameter of the introducer sheath. FIG. 17B shows a cross-section thenose cone 122 and the sheath 106 in a delivery position with theprosthetic valve retained in a compressed delivery state inside thesheath 106 (for purposes of illustration, only the stent 12 of theprosthetic valve is shown). As shown, the proximal end 180 of theintermediate section 176 can abut the distal end of the sheath 106 and atapered proximal surface 182 of the nose cone can extend within a distalportion of the stent 12.

As noted above, the delivery apparatus 100 can include a valve-retainingmechanism 114 (FIG. 8B) for releasably retaining a stent 12 of aprosthetic valve. The valve-retaining mechanism 114 can include a firstvalve-securement component in the form of an outer fork 130 (as bestshown in FIG. 12) (also referred to as an “outer trident” or “releasetrident”), and a second valve-securement component in the form of aninner fork 132 (as best shown in FIG. 17) (also referred to as an “innertrident” or “locking trident”). The outer fork 130 cooperates with theinner fork 132 to form a releasably connection with the retaining arms30 of the stent 12.

The proximal end of the outer fork 130 is connected to the distalsegment 126 of the outer shaft 104 and the distal end of the outer forkis releasably connected to the stent 12. In the illustrated embodiment,the outer fork 130 and the distal segment 126 can be integrally formedas a single component (e.g., the outer fork and the distal segment canbe laser cut or otherwise machined from a single piece of metal tubing),although these components can be separately formed and subsequentlyconnected to each other. The inner fork 132 can be mounted on the nosecatheter shaft 120 (as best shown in FIG. 17). The inner fork 132connects the stent to the distal end portion of the nose catheter shaft120. The nose catheter shaft 120 can be moved axially relative to theouter shaft 104 to release the prosthetic valve from the valve-retainingmechanism, as further described below.

As best shown in FIG. 12, the outer fork 130 includes a plurality ofangularly-spaced prongs 134 (three in the illustrated embodiment)corresponding to the retaining arms 30 of the stent 12, which prongsextend from the distal end of distal segment 126. The distal end portionof each prong 134 includes a respective opening 140. As best shown inFIG. 17, the inner fork 132 includes a plurality of angularly-spacedprongs 136 (three in the illustrated embodiment) corresponding to theretaining arms 30 of the stent 12, which prongs extend from a baseportion 138 at the proximal end of the inner fork. The base portion 138of the inner fork is fixedly secured to the nose catheter shaft 120(e.g., with a suitable adhesive) to prevent axial and rotationalmovement of the inner fork relative to the nose catheter shaft 120.

Each prong of the outer fork 130 cooperates with a corresponding prong136 of the inner fork to form a releasable connection with a retainingarm 30 of the stent. In the illustrated embodiment, for example, thedistal end portion of each prong 134 is formed with an opening 140. Whenthe prosthetic valve is secured to the delivery apparatus (as best shownin FIG. 19), each retaining arm 30 of the stent 12 extends inwardlythrough an opening 140 of a prong 134 of the outer fork and a prong 136of the inner fork is inserted through the opening 32 of the retainingarm 30 so as to retain the retaining arm 30 from backing out of theopening 140. FIG. 30 also shows the prosthetic valve 10 secured to thedelivery apparatus by the inner and outer forks before the prostheticvalve is loaded into the sheath 106. The threaded nut 150 can be seenpositioned between the prongs of the outer fork 130. The prostheticvalve 10 is ready to be compressed and loaded into the sheath 106 of adelivery apparatus. Retracting the inner prongs 136 proximally (in thedirection of arrow 184 in FIG. 20) to remove the prongs from theopenings 32 is effective to release the prosthetic valve 10 from theretaining mechanism. When the inner fork 132 is moved to a proximalposition (FIG. 20), the retaining arms 30 of the stent can move radiallyoutwardly from the openings 140 in the outer fork 130 under theresiliency of the stent. In this manner, the valve-retaining mechanism114 forms a releasable connection with the prosthetic valve that issecure enough to retain the prosthetic valve relative to the deliveryapparatus to allow the user to fine tune or adjust the position of theprosthetic valve after it is deployed from the delivery sheath. When theprosthetic valve is positioned at the desired implantation site, theconnection between the prosthetic valve and the retaining mechanism canbe released by retracting the nose catheter shaft 120 relative to theouter shaft 104 (which retracts the inner fork 132 relative to the outerfork 130).

Once the prosthetic valve 10 is loaded in the delivery sheath 106, thedelivery apparatus 100 can be inserted into the patient's body fordelivery of the prosthetic valve. In one approach, the prosthetic valvecan be delivered in a retrograde procedure where delivery apparatus isinserted, for example, into a femoral artery and advanced through thepatient's vasculature to the heart. Prior to insertion of the deliveryapparatus, an introducer sheath can be inserted into the femoral arteryfollowed by a guide wire, which is advanced through the patient'svasculature through the aorta and into the left ventricle. The deliveryapparatus 100 can then be inserted through the introducer sheath andadvanced over the guide wire until the distal end portion of thedelivery apparatus containing the prosthetic valve 10 is advanced to alocation adjacent to or within the native aortic valve.

Thereafter, the prosthetic valve 10 can be deployed from the deliveryapparatus 100 by rotating the torque shaft 110 relative to the outershaft 104. As described below, the proximal end of the torque shaft 110can be operatively connected to a manually rotatable handle portion or amotorized mechanism that allows the surgeon to effect rotation of thetorque shaft 110 relative to the outer shaft 104. Rotation of the torqueshaft 110 and the screw 112 causes the nut 150 and the sheath 106 tomove in the proximal direction toward the outer shaft (FIG. 22), whichdeploys the prosthetic valve from the sheath. Rotation of the torqueshaft 110 causes the sheath to move relative to the prosthetic valve ina precise and controlled manner as the prosthetic valve advances fromthe open distal end of the delivery sheath and begins to expand. Hence,unlike known delivery apparatus, as the prosthetic valve begins toadvance from the delivery sheath and expand, the prosthetic valve isheld against uncontrolled movement from the sheath caused by theexpansion force of the prosthetic valve against the distal end of thesheath. In addition, as the sheath 106 is retracted, the prostheticvalve 10 is retained in a stationary position relative to the ends ofthe inner shaft 120 and the outer shaft 104 by virtue of thevalve-retaining mechanism 114. As such, the prosthetic valve 10 can beheld stationary relative to the target location in the body as thesheath is retracted. Moreover, after the prosthetic valve is partiallyadvanced from the sheath, it may be desirable to retract the prostheticvalve back into the sheath, for example, to reposition the prostheticvalve or to withdraw the prosthetic valve entirely from the body. Thepartially deployed prosthetic valve can be retracted back into thesheath by reversing the rotation of the torque shaft, which causes thesheath 106 to advance back over the prosthetic valve in the distaldirection.

In known delivery devices, the surgeon must apply push-pull forces tothe shaft and/or the sheath to unsheathe the prosthetic valve. It istherefore difficult to transmit forces to the distal end of the devicewithout distorting the shaft (e.g., compressing or stretching the shaftaxially), which in turn causes uncontrolled movement of the prostheticvalve during the unsheathing process. To mitigate this effect, the shaftand/or sheath can be made more rigid, which is undesirable because thedevice becomes harder to steer through the vasculature. In contrast, themanner of unsheathing the prosthetic valve described above eliminatesthe application of push-pull forces on the shaft, as required in knowndevices, so that relatively high and accurate forces can be applied tothe distal end of the shaft without compromising the flexibility of thedevice. In certain embodiments, as much as about 90 N (about 20 lb) offorce can be transmitted to the end of the torque shaft withoutadversely affecting the unsheathing process. In contrast, prior artdevices utilizing push-pull mechanisms typically cannot exceed about 20N (5 lb) of force during the unsheathing process.

After the prosthetic valve 10 is advanced from the delivery sheath andexpands to its functional size (the expanded prosthetic valve 10 securedto the delivery apparatus is depicted in FIG. 30), the prosthetic valveremains connected to the delivery apparatus via the retaining mechanism114. Consequently, after the prosthetic valve is advanced from thedelivery sheath, the surgeon can reposition the prosthetic valverelative to the desired implantation position in the native valve suchas by moving the delivery apparatus in the proximal and distaldirections or side to side, or rotating the delivery apparatus, whichcauses corresponding movement of the prosthetic valve. The retainingmechanism 114 desirably provides a connection between the prostheticvalve and the delivery apparatus that is secure and rigid enough toretain the position of the prosthetic valve relative to the deliveryapparatus against the flow of the blood as the position of theprosthetic valve is adjusted relative to the desired implantationposition in the native valve. Once the surgeon positions the prostheticvalve at the desired implantation position in the native valve, theconnection between the prosthetic valve and the delivery apparatus canbe released by retracting the innermost shaft 120 in the proximaldirection relative to the outer shaft 104, which is effective to retractthe inner fork 132 to withdraw its prongs 136 from the openings 32 inthe retaining arms 30 of the prosthetic valve (FIG. 20). Slightlyretracting of the outer shaft 104 allows the outer fork 130 to back offthe retaining arms 30 of the prosthetic valve, which slide outwardlythrough openings 140 in the outer fork to completely disconnect theprosthetic valve from the retaining mechanism 114. Thereafter, thedelivery apparatus can be withdrawn from the body, leaving theprosthetic aortic valve 10 implanted within the native valve (such asshown in FIGS. 5A and 5B).

The delivery apparatus 100 has at its distal end a semi-rigid segmentcomprised of relatively rigid components used to transform rotation ofthe torque shaft into axial movement of the sheath. In particular, thissemi-rigid segment in the illustrated embodiment is comprised of theprosthetic valve and the screw 112. An advantage of the deliveryapparatus 100 is that the overall length of the semi-rigid segment isminimized because the nut 150 is used rather than internal threads onthe outer shaft to affect translation of the sheath. The reduced lengthof the semi-rigid segment increases the overall flexibility along thedistal end portion of the delivery catheter. Moreover, the length andlocation of the semi-rigid segment remains constant because the torqueshaft does not translate axially relative to the outer shaft. As such,the curved shape of the delivery catheter can be maintained during valvedeployment, which improves the stability of the deployment. A furtherbenefit of the delivery apparatus 100 is that the ring 128 prevents thetransfer of axial loads (compression and tension) to the section of thetorque shaft 110 that is distal to the ring.

In an alternative embodiment, the delivery apparatus can be adapted todeliver a balloon-expandable prosthetic valve. As described above, thevalve retaining mechanism 114 can be used to secure the prosthetic valveto the end of the delivery apparatus. Since the stent of the prostheticvalve is not self-expanding, the sheath 106 can be optional. Theretaining mechanism 114 enhances the pushability of the deliveryapparatus and prosthetic valve assembly through an introducer sheath.

FIGS. 23-26 illustrate the proximal end portion of the deliveryapparatus 100, according to one embodiment. The delivery apparatus 100can comprise a handle 202 that is configured to be releasablyconnectable to the proximal end portion of a catheter assembly 204comprising catheters 102, 108, 118. It may be desirable to disconnectthe handle 202 from the catheter assembly 204 for various reasons. Forexample, disconnecting the handle can allow another device to be slidover the catheter assembly, such as a valve-retrieval device or a deviceto assist in steering the catheter assembly. It should be noted that anyof the features of the handle 202 and the catheter assembly 204 can beimplemented in any of the embodiments of the delivery apparatusesdisclosed herein.

FIGS. 23 and 24 show the proximal end portion of the catheter assembly204 partially inserted into a distal opening of the handle 202. Theproximal end portion of the main shaft 104 is formed with an annulargroove 212 (as best shown in FIG. 24) that cooperates with a holdingmechanism, or latch mechanism, 214 inside the handle. When the proximalend portion of the catheter assembly is fully inserted into the handle,as shown in FIGS. 25 and 26, an engaging portion 216 of the holdingmechanism 214 extends at least partially into the groove 212. One sideof the holding mechanism 214 is connected to a button 218 that extendsthrough the housing of the handle. The opposite side of the holdingmechanism 214 is contacted by a spring 220 that biases the holdingmechanism to a position engaging the main shaft 104 at the groove 212.The engagement of the holding mechanism 214 within the groove 212prevents axial separation of the catheter assembly from the handle. Thecatheter assembly can be released from the handle by depressing button218, which moves the holding mechanism 214 from locking engagement withthe main shaft. Furthermore, the main shaft 104 can be formed with aflat surface portion within the groove 212. The flat surface portion ispositioned against a corresponding flat surface portion of the engagingportion 216. This engagement holds the main shaft 104 stationaryrelative to the torque shaft 110 as the torque shaft is rotated duringvalve deployment.

The proximal end portion of the torque shaft 110 can have a driven nut222 (FIG. 26) that is slidably received in a drive cylinder 224 (FIG.25) mounted inside the handle. The nut 222 can be secured to theproximal end of the torque shaft 100 by securing the nut 222 over acoupling member 170 (FIG. 15). FIG. 26 is a perspective view of theinside of the handle 202 with the drive cylinder and other componentsremoved to show the driven nut and other components positioned withinthe drive cylinder. The cylinder 224 has a through opening (or lumen)extending the length of the cylinder that is shaped to correspond to theflats of the nut 222 such that rotation of the drive cylinder iseffective to rotate the nut 222 and the torque shaft 110. The drivecylinder can have an enlarged distal end portion 236 that can house oneor more seals (e.g., O-rings 246) that form a seal with the outersurface of the main shaft 104 (FIG. 25). The handle can also house afitting 238 that has a flush port in communication with the lumen of thetorque shaft and/or the lumen of the main shaft.

The drive cylinder 224 is operatively connected to an electric motor 226through gears 228 and 230. The handle can also house a batterycompartment 232 that contains batteries for powering the motor 226.Rotation of the motor in one direction causes the torque shaft 110 torotate, which in turn causes the sheath 106 to retract and uncover aprosthetic valve at the distal end of the catheter assembly. Rotation ofthe motor in the opposite direction causes the torque shaft to rotate inan opposite direction, which causes the sheath to move back over theprosthetic valve. An operator button 234 on the handle allows a user toactivate the motor, which can be rotated in either direction toun-sheath a prosthetic valve or retrieve an expanded or partiallyexpanded prosthetic valve.

As described above, the distal end portion of the nose catheter shaft120 can be secured to an inner fork 132 that is moved relative to anouter fork 130 to release a prosthetic valve secured to the end of thedelivery apparatus. Movement of the shaft 120 relative to the main shaft104 (which secures the outer fork 130) can be effected by a proximal endportion 240 of the handle that is slidable relative to the main housing244. The end portion 240 is operatively connected to the shaft 120 suchthat movement of the end portion 240 is effective to translate the shaft120 axially relative to the main shaft 104 (causing a prosthetic valveto be released from the inner and outer forks). The end portion 240 canhave flexible side panels 242 on opposite sides of the handle that arenormally biased outwardly in a locked position to retain the end portionrelative to the main housing 244. During deployment of the prostheticvalve, the user can depress the side panels 242, which disengage fromcorresponding features in the housing and allow the end portion 240 tobe pulled proximally relative to the main housing, which causescorresponding axial movement of the shaft 120 relative to the mainshaft. Proximal movement of the shaft 120 causes the prongs 136 of theinner fork 132 to disengage from the apertures 32 in the stent 12, whichin turn allows the retaining arms 30 of the stent to deflect radiallyoutwardly from the openings 140 in the prongs 134 of the outer fork 130,thereby releasing the prosthetic valve.

FIG. 27 shows an alternative embodiment of a motor, indicated at 300,that can be used to drive a torque shaft (e.g., torque shaft 110). Inthis embodiment, a catheter assembly can be connected directly to oneend of a shaft 302 of the motor, without gearing. The shaft 302 includesa lumen that allows for passage of an innermost shaft (e.g., shaft 120)of the catheter assembly, a guide wire, and/or fluids for flushing thelumens of the catheter assembly.

Alternatively, the power source for rotating the torque shaft 110 can bea hydraulic power source (e.g., hydraulic pump) or pneumatic(air-operated) power source that is configured to rotate the torqueshaft. In another embodiment, the handle can have a manually movablelever or wheel that is operable to rotate the torque shaft 110.

In another embodiment, a power source (e.g., an electric, hydraulic, orpneumatic power source) can be operatively connected to a shaft, whichis turn is connected to a prosthetic valve 10. The power source isconfigured to reciprocate the shaft longitudinally in the distaldirection relative to a valve sheath in a precise and controlled mannerin order to advance the prosthetic valve from the sheath. Alternatively,the power source can be operatively connected to the sheath in order toreciprocate the sheath longitudinally in the proximal direction relativeto the prosthetic valve to deploy the prosthetic valve from the sheath.

Referring to FIG. 31, there is shown a prosthetic aortic heart valve410, according to another embodiment. Similar to the prosthetic valve10, the prosthetic valve 410 includes an expandable frame member, orstent, 412 that supports an expandable valve member, which in theillustrated embodiment comprises a flexible leaflet section 414. Also,the prosthetic valve 410 is radially compressible to a compressed statefor delivery through the body to a deployment site and expandable to itsfunctional size shown in FIG. 31 at the deployment site. In certainembodiments, the prosthetic valve 410 is self-expanding; that is, theprosthetic valve can radially expand to its functional size whenadvanced from the distal end of a delivery sheath. In other embodiments,the prosthetic valve can be a balloon-expandable prosthetic valve thatcan be adapted to be mounted in a compressed state on the balloon of adelivery catheter. The prosthetic valve can be expanded to itsfunctional size at a deployment site by inflating the balloon, as knownin the art. Apparatuses particularly suited for percutaneous deliveryand implantation of the prosthetic valve 10 (such as those describedherein) are also suitable for percutaneous delivery and implantation ofthe prosthetic valve 410. The illustrated prosthetic valve 410 isadapted to be deployed in the native aortic annulus, although it alsocan be used to replace the other native valves of the heart (the mitral,tricuspid and pulmonary valves). Moreover, the prosthetic valve 410 canbe adapted to replace other valves within the body, such venous valves.

The frame member 412 of the prosthetic valve 410 can have the sameoverall shape and construction as the frame member 12 of the prostheticvalve 10. Thus, similar to the frame member 12, the frame member 412 canbe formed from a plurality of longitudinally extending, generallysinusoidal shaped frame members, or struts, 416. Referring to FIG. 31,the stent 412 has an inflow end 426 and an outflow end 427, and the meshstructure formed by the struts 416 comprises a generally cylindrical“upper” or outflow end portion 420, an outwardly bowed or distendedintermediate section 422, and an inwardly bowed “lower” or inflow endportion 424. Further, the stent 412 can have a plurality of angularlyspaced retaining arms, or projections, in the form of posts 430 (threein the illustrated embodiment) that extend from upper portion of thestent 412. Each retaining arm 430 has a respective aperture 432 that issized to receive prongs of a valve-retaining mechanism that can be usedto form a releasable connection between the prosthetic valve and adelivery apparatus (described above). In alternative embodiments, theretaining arms 430 need not be provided if a valve-retaining mechanismis not used. In further embodiments, the retaining arms 430 can extendfrom the lower portion of the stent 424, for example, for applicationsinvolving antegrade implantation of the valve (e.g., the deliveryapparatus is inserted through a surgical opening in the wall of the leftventricle of the heart in a transventricular approach, such as anopening made at the bare spot on the lower anterior ventricle wall).

The leaflet assembly 414 of the prosthetic aortic heart valve 410 issimilar to the leaflet assembly 14 of the prosthetic aortic heart valve10, although there are several differences, described below. Forexample, with reference to FIGS. 32 and 33, the leaflet assembly 414comprises three leaflets 434 a, 434 b, 434 c made of a flexiblematerial. Each leaflet has an inflow end portion 460 and an outflow endportion 462. The leaflets can comprise any suitable biological material(e.g., pericardial tissue, such as bovine or equine pericardium),bio-compatible synthetic materials, or other such materials, such asthose described in U.S. Pat. No. 6,730,118, which is incorporated hereinby reference. The leaflet assembly 414 can include an annularreinforcing skirt assembly 442 that is secured to the inflow endportions of the leaflets 434 a, 434 b, 434 c at a suture line 444adjacent the inflow end of the prosthetic valve. The inflow end portionof the leaflet assembly 414 can be secured to the stent 412 by suturingthe skirt assembly 442 to the struts 416 of the lower section 424 of thestent (best shown in FIG. 31).

With reference to FIG. 33, the skirt assembly 442 can include an upperskirt 443 and a lower skirt 445. The inflow end portions 460 of theleaflets 434 a, 434 b, and 434 c can be positioned between an upperportion 447 of the lower skirt 445 and a lower portion 454 of the upperskirt 443, with the upper skirt desirably having an outward placementcompared to the lower skirt. The upper skirt 443, the inflow endportions 460 of the leaflets 434 a, 434 b, 434 c, and the lower skirt445 can be secured by sutures along a scalloped or undulating sutureline 444 adjacent the inflow end of the prosthetic valve (FIG. 31). Theinflow end portion of the leaflet assembly 414 can be secured to thestent 412 by suturing the upper skirt 443, the lower skirt 445, or boththe upper skirt 443 and the lower skirt 445 to the struts 416 of thelower section 424 of the stent via sutures 455 (best shown in FIG. 31).The skirt assembly 442 (including the upper skirt 443 and the lowerskirt 445), desirably can be made of a bio-compatible syntheticmaterial, such as polytetrafluoroethylene (PTFE), or a woven fabricmaterial, such as woven polyester (e.g., polyethylene terephthalate)(PET), DACRON®). The upper skirt 443 and the lower skirt 445 can be madeof the same, or different, material.

As best shown in FIG. 32, the outflow end portion of upper skirt 443 canbe shaped to substantially align with the undulating or zigzag shapeformed by the struts 416 of the lower section 424 of the stent, e.g.,for ease of securing the upper skirt to the struts of the stent bysuture. For example, the upper skirt 443 can include an upper edge 456shaped to correspond to the shape of the second lowermost row of cellsof the frame member 412. The inflow end portion of upper skirt 443 canhave an undulating lower edge 458 that substantially aligns with theundulating suture line 444 and the scalloped or undulating shape of theinflow portions of the leaflets 443 a, 443 b, and 443 c. The outflow endportion of the lower skirt 445 can be shaped to have an undulating shapethat substantially corresponds with the undulating suture line 444. Theinflow end portion 454 of the upper skirt 443 and the outflow endportion 447 of the lower skirt 445 overlap each other on opposite sidesof the leaflet inflow end portions at least enough to secure the upperskirt and lower skirt by sutures along the suture line 444. The inflowend portion of the lower skirt 445 typically extends to the inflow end426 of the stent, although other configurations are possible. Forexample, the inflow end portion of the lower skirt 445 can be shaped toinclude a lower edge shaped to correspond to the shape of a lowermostrow of cells of the frame.

The outflow end portion of the leaflet assembly 414 can be secured tothe upper portion of the stent 412 at three angularly spaced commissureattachments of the leaflets 434 a, 434 b, 434 c, in a manner similar tothe configuration used to secure the outflow end portion of the leafletassembly 14 to the upper portion of the stent 12 at three angularlyspaced commissure attachments of the leaflets 34 a, 34 b, 34 c (as bestshown in FIG. 2).

FIG. 33 shows the operation of the prosthetic valve 410. Duringdiastole, the leaflets 434 a, 434 b, 434 c collapse to effectively closethe prosthetic valve. As shown, the curved shape of the intermediatesection 422 of the stent 412 defines a space between the intermediatesection and the leaflets that mimics the sinuses of Valsalva. Thus, whenthe leaflets close, backflow entering the “sinuses” creates a turbulentflow of blood along the upper surfaces of the leaflets, as indicated byarrows 452. This turbulence assists in washing the leaflets and theskirt assembly 442 to minimize clot formation.

Referring to FIGS. 33 and 35, the prosthetic valve 410 can furtherinclude a sealing skirt 449 positioned at the lower section 424 of thestent. The sealing skirt 449 provides an additional barrier againstparavalvular leakage following implantation of the stent in a subject byproviding material at the inflow end portion of the stent that protrudesoutwardly through the openings of the cells of the frame and contactssurrounding tissue of the native annulus, thereby minimizing or reducingparavalvular leakage. The sealing skirt is desirably supported by theupper skirt 443 and the lower skirt 445, which prevent the sealing skirt449 from contacting the leaflets 434 a, 434 b, and 434 c of the leafletassembly 414. The upper skirt 443 and the lower skirt 445 additionallyprovide support to ensure that the material of the sealing skirt 449extends outwardly between cells formed by the struts 416 of the stent412 to seal against the surrounding annulus.

FIG. 34 depicts an embodiment of the sealing skirt 449 prior toattachment to the stent. The outflow end portion 451 of the sealingskirt 449 can have an undulating or zigzag shape that has an upper edgeshaped to correspond to the shape of the upper boundary of a lower mostrow of cells of the frame formed by the struts 416 of the stent 412. Inalternative embodiments, the outflow end portion 451 of the sealingskirt 449 can have a substantially straight edge that does not alignwith the undulating or zigzag shape formed by the struts 416 of thestent 412; instead the outflow end portion 451 of the sealing skirt 449can transect the lower most row of cells of the frame formed by thestruts 416 of the stent 412 (see, e.g., FIG. 38). The inflow end portion453 of the sealing skirt 449 typically extends to the inflow end 426 ofthe stent (see, e.g., FIGS. 35 and 36), although other configurationsare possible. For example, the sealing skirt 449 can have an upper edgeand a lower edge shaped to correspond to the shape of a lower most rowof cells formed by the struts 416 of the inflow end 426 of the stentsuch that the sealing skirt 449 only occludes the openings in thelowermost row of cells (see, e.g., FIG. 37). In additional embodiments,the inflow end portion of the sealing skirt 449 can be constructed toextend beyond the inflow end 426 of the stent (see, e.g., FIG. 38). Inseveral embodiments, the inflow end portion 453 of the sealing skirt 449can be shaped to substantially align with the inflow end portion of thelower skirt 445.

Referring to FIGS. 35-39, the sealing skirt 449 can be secured to thestruts 416 of the lower portion of the stent 412 with sutures 455. Thesutures 455 can secure the sealing skirt 449 to the struts 416 of thelower portion of the stent 412, and optionally can also secure the upperskirt 443 and/or the lower skirt 445 to the struts 416 of the lowerportion of the stent 412. The sealing skirt 449 desirably is made of abio-compatible synthetic material, such as polytetrafluoroethylene(PTFE), or a woven fabric material, such as woven polyester (e.g.,polyethylene terephthalate) (PET), DACRON®). In several embodiments, thesealing skirt comprises a plush or pile material, such as a loop yarn,which functions as a filler material in that fibers of the sealing skirtcan extend outwardly through openings in the frame and fill spacesbetween the frame and the native annulus. The plush or pile material isalso compressible, thus minimizing the crimp profile of the sealingskirt 449. In some embodiments, the sealing skirt can be made of a PETloop yarn or polyester 70/20 textured yarn. In additional embodiments,the sealing skit can be made of polyester multifilament partiallyoriented yarn (poy); a polyester 2-ply multifilament yarn; a polyesterfilm; a knitted polyester; a woven polyester; and/or a felted polyester.Such materials are available commercially, for example, from BiomedicalStructures (Warwick, R.I.) and ATEX Technologies (Pinebluff, N.C.).

With reference to FIG. 39, the illustrated embodiment of the sealingskirt 449 can be made of a relatively less bulky, non-plush or non-pilematerial (e.g., woven PET fabric) and secured (e.g., with sutures 455)to the frame member 412 such that portions of the sealing skirt protruderadially outwardly through the cells of the frame member 412 to sealagainst the surrounding annulus. In such embodiments, the sealing skirtcan be secured by sutures 455 such that slack material of sealing skirt449 bulges or protrudes through the lowermost cells formed by the struts416 of the frame member 412. The lower skirt 445 supports the sealingskirt 449 (and can be secured to the frame member 412 with the samesutures 455 as used to secure the sealing skirt 449) to prevent theslack material of the sealing skirt from protruding inwardly towards thelongitudinal axis of the valve 410 and contacting the leaflets. In suchembodiments, the length of the sealing skirt 449 is typically longerthan that of the inner circumference of the lower portion of the framemember 412. FIG. 39 provides a perspective view depicting a portion ofthe frame member 412 and the sealing skirt 449; however, for clarity ofillustration, the upper skirt 443, the lower skirt 445 and the leafletassembly 434 are not depicted.

The dimensions of the sealing skirt 449 can be adjusted to obtain thedesired amount of material protruding from an expanded annular frame,depending on the type of material used for the sealing skirt. Forexample, in embodiments where the sealing skirt 449 is constructed of aplush or pile material (such as a loop yarn) having fibers that protrudeoutwardly between the cells of the frame member 412, the length of thesealing skirt (in an unrolled or flattened configuration prior tomounting on the frame) can be substantially the same as thecircumference of the lower portion of the frame member 412. In otherembodiments, the length of the sealing skirt prior to mounting on theannular frame is at least about 5% (such as at least about 10%, at leastabout 15%, at least about 20%, at least about 25%) longer than thecircumference of the expanded annular frame of the stent, to allow foradditional material to protrude between the cells of the frame member412.

Although description of the sealing skirt 449 above is made withreference to prosthetic heart valve 410, the sealing skirt can also beincluded on prosthetic heart valve 10, for example, by modifying thedimensions of the sealing skirt 449 as needed to secure the sealingskirt 449 to skirt assembly 42 of heart valve 10.

The prosthetic valve 410 can be implanted in a retrograde approach wherethe prosthetic valve, mounted in a crimped state at the distal end of adelivery apparatus (e.g., the delivery apparatus 100), is introducedinto the body via the femoral artery and advanced through the aorticarch to the heart, as further described in U.S. Patent ApplicationPublication No. 2008/0065011, which is incorporated herein by reference.The prosthetic valve 410 can also be implanted in a retrograde approachwhere the prosthetic valve, mounted in a crimped state at the distal endof a delivery apparatus (e.g., the delivery apparatus 100), isintroduced into the body via the left or right subclavian artery andadvanced to the heart. In further embodiments, the prosthetic valve 410can be implanted in an antegrade approach where the prosthetic valve,mounted in a crimped state at the distal end of a delivery apparatus, isintroduced into the body and advanced transventricularly (see, e.g.,U.S. Pat. No. 8,439,970, which is incorporated herein by reference. Fortransventricular implant applications, the retaining arms 430 can beincluded on the lower portion of the stent.

Prior to insertion of the delivery apparatus, an introducer sheath canbe inserted into the artery followed by a guide wire, which is advancedthrough the patient's vasculature through the aorta and into the leftventricle. The delivery apparatus can then be inserted through theintroducer sheath and advanced over the guide wire until the distal endportion of the delivery apparatus containing the prosthetic valve 410 isadvanced to a location adjacent to or within the native aortic valve.

Known introducer sheaths typically employ a sleeve made from polymerictubing having a radial wall thickness of from about 0.025 mm (about0.010 inch) to about 0.04 mm (about 0.015 inch). FIG. 40A shows anembodiment of an introducer sheath, indicated at 500, that employs athin metallic tubular layer that has a much smaller wall thicknesscompared to known devices. In particular embodiments, the wall thicknessof the sheath 500 is from about 0.0012 mm (about 0.0005 inch) to about0.05 mm (about 0.002 inch). The introducer sheath 500 includes aproximally located housing or hub 502 and a distally extending sleeve orcannula 504. The housing 502 can house a seal or a series of seals asknown in the art to minimize blood loss. The sleeve 504 comprises atubular layer or sleeve 506 that is formed from a metal or metal alloy,such as Nitinol or stainless steel, and desirably is formed with aseries of circumferentially extending or helically extending slits oropenings to impart a desired degree of flexibility to the sleeve.

As shown in FIG. 40B, for example, the tubular layer 506 is formed(e.g., laser cut) with an “I-beam” pattern of alternating circular bands507 and openings 508 with axially extending connecting portions 510connecting adjacent bands 507. Two adjacent bands 507 can be connectedby a plurality of angularly spaced connecting portions 510, such as fourconnecting portions 510 spaced about 90 degrees from each other aroundthe axis of the sleeve, as shown in the illustrated embodiment. Thesleeve 504 exhibits sufficient flexibility to allow the sleeve to flexas it is pushed through a tortuous pathway without kinking or buckling.FIG. 41 shows another pattern of openings that can be laser cut orotherwise formed in the tubular layer 506. The tubular layer in theembodiment of FIG. 41 has a pattern of alternating bands 512 andopenings 514 with connecting portions 516 connecting adjacent bands 512,the openings 514 and connecting portions 516 each arranged in a helicalpattern along the length of the sleeve. In alternative embodiments, thepattern of bands and openings and/or the width of the bands and/oropenings can vary along the length of the sleeve in order to varystiffness of the sleeve along its length. For example, the width of thebands can decrease from the proximal end to the distal end of the sleeveto provide greater stiffness near the proximal end and greaterflexibility near the distal end of the sleeve.

As shown in FIG. 42, the sleeve 504 can have a thin outer layer or liner518 extending over the tubular layer 506, the outer layer 518 made of alow friction material to reduce friction between the sleeve and thevessel wall into which the sleeve is inserted. The sleeve 504 can alsohave a thin inner layer or liner 520 covering the inner surface of thetubular layer 506 and made of a low friction material to reduce frictionbetween the sleeve and the delivery apparatus that is inserted into thesleeve. The inner and outer layers can be made from a suitable polymer,such as PET, PTFE, FEP, and/or polyether block amide (PEBAX®). The innerand outer liners, and the tubular layer, are sized appropriately for thedesired application of the introducer sheath 500. In particularembodiments, the inner liner 520 can have a radial wall thickness in therange of from about 0.0012 mm (about 0.0005 inch) to about 0.012 mm(about 0.005 inch) (such as from about 0.025 mm (about 0.001 inch) toabout 0.075 mm (0.003 inch), for example about 0.06 mm (about 0.0025inch)). In particular embodiments, the outer liner 518 has a radial wallthickness in the range of about from about 0.0012 mm (0.0005 inch) toabout 0.012 mm (about 0.005 inch) (such as from about 0.012 mm (about0.0005 inch) to about 0.075 mm (0.003 inch), for example about 0.025 mm(about 0.001 inch)). In particular embodiments, the tubular layer 506can have a radial wall thickness in the range of from about 0.0012 mm(about 0.0005 inch) to about 0.025 mm (about 0.01 inch) (such as fromabout 0.05 mm (about 0.002 inch) to about 0.15 mm (about 0.006 inch),for example about 0.05 mm (about 0.002 inch) or about 0.1 mm (about0.004 inch)).

Together, the inner liner 520, the tubular layer 506, and the outerlayer 518, have a wall thickness that can vary based on the desiredfinal product. In some embodiments, the inner liner 520, the tubularlayer 506, and the outer layer 518, together can have a radial wallthickness in the range of from about 0.05 mm (about 0.002 inch) to about0.5 mm (about 0.02 inch) (such as from about 0.09 mm (about 0.0035 inch)to about 0.3 mm (about 0.012 inch). As such, the sleeve 504 can beprovided with an outer diameter that is about 1-2 Fr smaller than knowndevices. The relatively smaller profile of the sleeve 504 improves easeof use, lowers risk of patient injury via tearing of the arterial walls,and increases the potential use of minimally invasive procedures (e.g.,heart valve replacement) for patients with highly calcified arteries,tortuous pathways or small vascular diameters.

The inner liner 520 can be applied to the interior of the tubular layer506, for example, using a two-stage molding process. In one step, apreform, cylindrical polymer tube or parison 522 (FIG. 48) with an openend 524 and a closed end 526 is formed, e.g., by an injection molding orextrusion process. The tube 522 has an outer diameter less than that ofthe inner diameter of the tubular layer 506, and a wall thicknessdesigned to provide an appropriate thickness for the inner liner 520 ofthe tubular layer 506, following blow molding. In one embodiment, thetube 522 can have a wall thickness of from about 0.025 mm (about 0.001inch) to about 0.1 mm (about 0.004 inch) (such as from about 0.05 mm(about 0.002 inch) to about 0.075 mm (about 0.003 inch), such as about0.06 mm (about 0.0025 inch)). Appropriate material for the polymer tubecan be selected based on the desired finished product. In someembodiments, the polymer tube 522 is made of nylon-12, polyethylene,fluorinated ethylene propylene, and/or polyether block amide (e.g.,PEBAX® 72D). The length of the tube 522 can be varied depending on thelength of the tubular layer 506, and is typically longer than that ofthe tubular layer 506. In another step, heat and pressure are applied tothe tube 522 to form the inner liner 520 by blow molding.

FIGS. 48 and 49 depict an exemplary method of using blow molding toapply the tube 522 to the tubular layer 506 to form the inner liner 520.The tubular layer 506 is inserted into mold 528. The mold 528, which hasan inner diameter that is slightly larger than the outer diameter of thetubular layer 506 such that the sleeve can be easily inserted into andremoved from the mold, prevents any appreciable radial expansion of thesleeve during the pressurization step (described below). The mold 528can be constructed to be non-expandable during blow molding of the tube522. The mold 528 can have a cylindrical inner surface 529 thatcorresponds to the shape of the outer surface of the tubular layer 506.Thus, when the tube 522 is pressurized (discussed in detail below), theinner surface of the mold prevents the tubular layer 506 fromexpanding/deforming under pressure from the expanding tube 522 andprevents portions of the tube 522 from expanding radially outwardlythrough the openings 508 in the tubular layer 506.

The tube 522 with the open end 524 and the closed end 526 is insertedinto the tubular layer 506, as shown in FIG. 48. The closed end 526 canextend beyond one end of the tubular layer 506, and the open end 524 canextend beyond the other end of tubular layer 506.

Heat and pressure are applied to the tube 522 to cause the tube toexpand against the inner surface of the tubular layer 506 to form anexpanded polymer tube 530. The heat and pressure can be appliedsequentially (e.g., heat is applied, then pressure), or simultaneously.For example, the heat and pressure can be applied simultaneously byinjecting heated compressed gas or liquid into the open end 524 of thetube 522. Alternatively, the heat can be applied by heating the mold528, and the tube 522 can be pressurized by injecting compressed gas orliquid into the open end 524 of the tube 522. For example, the entireassembly including the mold 528, the tubular layer 506, and the tube 522can be immersed in a heated fluid. In this regard, the wall of the moldcan have one or more apertures that allow the heated fluid (e.g., aheated liquid such as water) to flow through the apertures and contactthe tube 522 to facilitate heating of the tube. Various other types ofheat sources, such as resistive, conductive, convective, and infraredheat sources, can be used to apply heat to the tube 522. Optionally, thetube 522 can be stretched axially concurrently with heating and/orpressurizing, or in one or more separate stretching steps performed atseparate times from heating and/or pressurizing.

Portions of the expanded tube 530 extending beyond the either end oftubular layer 506 can be trimmed to form the inner liner 520 of tubularlayer 506. In some embodiments, the inner liner 520 can expand into theopenings 508 of the tubular layer 506 during the molding process, andremain in the openings following the molding process. In otherembodiments, the inner liner 520 does not expand into and/or remain intothe openings 508 of the tubular layer 506 during the molding process.The specific heat and pressure conditions (including the duration forwhich the heat and pressure should be applied, as well as coolingconditions) for blow molding the inner liner 520 of the tubular layer506 can be varied as desired, and typically will depend on the startingmaterials and desired finished product. In some embodiments, the tube522 is heated to about 125° C. (about 255° F.) and pressurized to about80 kPa (about 12 psi) for a period of time sufficient to form innerliner 520. Further, general methods of blow molding are known to theperson of ordinary skill in the art (see, e.g., U.S. Patent ApplicationPublication No. 2011/0165284, which is incorporated by reference hereinin its entirety).

The outer layer 518 of the sheath can be applied over and secured to theouter surface of the tubular layer 506 using conventional techniques ormechanisms (e.g., using an adhesive or by thermal welding). In oneembodiment, the outer layer is formed by shrink wrapping a polymertubular layer to tubular layer 506. Appropriate material for the outerlayer 518 can be selected based on the desired finished product. In someembodiments, the outer layer 518 is made of nylon-12, polyether blockamide (PEBAX®, e.g., PEBAX® 72D), and/or polyethylene. The outer layer518 can be applied to the tubular layer 506 before or after the innerlayer 520 has been formed using the molding process described above.

In a modification of the introducer sheath 500, the sheath can haveinner and outer layers 520, 518, respectively, which are secured to ametal sleeve (e.g., sleeve 504) only at the proximal and distal ends ofthe metal sleeve. The inner and outer polymeric layers can be bonded tothe metal sleeve (or to each other through the gaps in the metalsleeve), for example using a suitable adhesive or by thermal welding. Inthis manner, the metal sleeve is unattached to the inner and outerpolymeric layers between the proximal and distal ends of the sleevealong the majority of the length of the sleeve, and therefore is“free-floating” relative to the polymeric layers along the majority ofthe length of the sleeve. This construction allows the adjacent bands ofmetal to bend more easily relative to the inner and outer layers,providing the sheath with greater flexibility and kink-resistance thanif the inner and outer layers were bonded along the entire length of thesleeve.

FIG. 43 shows a segment of an alternative metal sleeve, indicated at600, that can be used in the introducer sheath 500. The sheath 500 inthis embodiment desirably includes inner and outer polymeric layers,which desirably are secured to the metal sleeve only at its proximal anddistal ends as discussed above. The sleeve 600 includes a plurality ofcircular bands or rings 602 interconnected by two links, or connectingportions, 604, extending between each pair of adjacent rings. Each pairof links connecting two adjacent bands 602 desirably are spaced about180 degrees from each other and desirably are rotationally offset byabout 90 degrees from an adjacent pair of links, which allows formulti-axial bending.

FIG. 44 shows side view of a segment of another embodiment of a metalsleeve, indicated at 700, that can be used in the introducer sheath 500.The sleeve 700 has the same cut pattern as the sleeve 600, and thereforehas circular bands 702 and two links 704 connecting adjacent bands, andfurther includes two cutouts, or apertures, 706 formed in each band 702to increase the flexibility of the sleeve. The cutouts 706 desirablyhave a generally elliptical or oval shape, but can have other shapes aswell. Each cutout 706 desirably extends about 180 degrees in thecircumferential direction of the sleeve and desirably is rotationaloffset by about 90 degrees from a cutout 706 in an adjacent band 702.

In particular embodiments, the metal sleeve of an introducer sheath hasa wall thickness in the range of from about 0.05 mm (about 0.002 inch)to about 0.015 mm (about 0.006 inch). In one implementation, a sheathhas a metal sleeve having a wall thickness of about 0.05 mm (about 0.002inch) and an inner diameter of about 5.8 mm (about 0.229 inch), an innerpolymeric layer having a wall thickness of about 0.06 mm (about 0.0025inch), an outer polymeric layer having a wall thickness of about 0.025mm (about 0.001 inch), and a total wall thickness (through all threelayers) of about 0.14 mm (about 0.0055 inch). In another implementation,a sheath has a metal sleeve having a wall thickness of about 0.1 mm(about 0.004 inch) and an inner diameter of about 5.8 mm (about 0.229inch), an inner polymeric layer having a wall thickness of about 0.06 mm(about 0.0025 inch), an outer polymeric layer having a wall thickness ofabout 0.025 mm (about 0.001 inch), and a total wall thickness (throughall three layers) of about 0.2 mm (about 0.0075 inch). FIG. 45 shows thecut pattern for forming the metal sleeve 600 of FIG. 43. FIG. 46 showsthe cut pattern for forming the metal sleeve 700 of FIG. 44. FIG. 47shows a cut pattern similar to the cut pattern of FIG. 46, but includingcutouts 706 that are narrower than the cutouts shown in FIG. 46.

TABLE 1 Minimum bend Minimum radius allowing Wall thickness of bendradius passage of metal sleeve Material without visual kink 16-Frdilator  0.1 mm (0.004″) Nitinol 2.5 cm (1″) 2.5 cm (1″)  0.1 mm(0.004″) Stainless steel 2.5 cm (1″) 2.5 cm (1″)  0.1 mm (0.002″)Nitinol  15 cm (6″) 2.5 cm (1″) 0.05 mm (0.002″) Stainless steel  15 cm(6″) 2.5 cm (1″) 0.05 mm (0.002″) Stainless steel   5 cm (2″) 2.5 cm(1″) (wide rings)

Table 1 above demonstrates the bend performance of several metalsleeves. Each metal sleeve had an inner diameter of about 5.8 mm (about0.229 inch). Each sleeve was formed with the cut pattern shown in FIG.44, except for the last sleeve in Table 1, which was formed with the cutpattern shown in FIG. 43. All of the sleeves in Table 1 provide devicedeliverability at a relatively small bend radius (2.5 cm, 1 inch).Furthermore, it was found that the metal sleeves recover their circularcross-sectional shapes even after passing a delivery device through avisibly kinked section of the sleeve.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples and should not betaken as limiting the scope of the disclosure. Moreover, additionalembodiments are disclosed in U.S. Patent Application Publication No.2010/0049313 (U.S. patent application Ser. No. 12/429,040) and U.S.Patent Application Publication No. 2012/0239142 (U.S. patent applicationSer. No. 13/405,119), each of which is incorporated herein by reference.Accordingly, the scope of the disclosure is defined by the followingclaims. We therefore claim all that comes within the scope and spirit ofthese claims.

What is claimed is:
 1. A method of making an introducer sheath with aninner liner for percutaneous insertion of a medical device into apatient, comprising: inserting a metal sleeve into a mold; inserting apolymer tube comprising a closed end and an open end into the metalsleeve; pressurizing and heating the polymer tube to cause the polymertube to expand against an inner surface of the metal sleeve so as toform the inner liner of the sheath.
 2. The method of claim 1, whereinthe preform cylindrical polymer tube is made of nylon-12, polyethylene,or fluorinated ethylene propylene.
 3. The method of claim 1, wherein thepolymer tube has a radial wall thickness in the range of from about0.025 mm (about 0.001 inch) to about 0.075 mm (about 0.003 inch).
 4. Themethod of claim 1, wherein the metal sleeve has a radial wall thicknessin the range of from about 0.05 mm (about 0.002) to 0.15 mm (about 0.006inch).
 5. The method of claim 1, wherein pressurizing and heating thepolymer tube comprises injecting heated compressed gas into the polymertube.
 6. The method of claim 1, wherein pressurizing the polymer tubecomprises injecting compressed gas into the polymer tube and whereinheating the polymer tube comprises heating with a heat source separatefrom the pressurized gas.
 7. The method of claim 1, wherein the metalsleeve comprises a plurality of circumferentially or helically extendingslots.
 8. The method of claim 1, wherein the introducer sheath isconfigured for percutaneous insertion of a prosthetic heart valvethrough the femoral artery of the patient.
 9. The method of claim 1,further comprising forming an outer polymer liner on the metal sleeve.10. A method of making an introducer sheath configured for percutaneousinsertion of a prosthetic heart valve through a blood vessel of thepatient, comprising: inserting a metal sleeve into a mold; inserting apolymer tube comprising a closed end and an open end into the metalsleeve; pressurizing and heating the polymer tube to cause the polymertube to expand against an inner surface of the metal sleeve so as toform the inner liner of the sheath, wherein pressurizing the polymertube comprises injecting compressed gas into the polymer tube.
 11. Themethod of claim 10, wherein the preform cylindrical polymer tube is madeof nylon-12, polyethylene, or fluorinated ethylene propylene.
 12. Themethod of claim 10, wherein the polymer tube has a radial wall thicknessin the range of from about 0.025 mm (about 0.001 inch) to about 0.075 mm(about 0.003 inch).
 13. The method of claim 10, wherein the metal sleevehas a radial wall thickness in the range of from about 0.05 mm (about0.002) to 0.15 mm (about 0.006 inch).
 14. The method of claim 10,wherein pressurizing and heating the polymer tube comprises injectingheated compressed gas into the polymer tube.
 15. The method of claim 10,wherein heating the polymer tube comprises heating with a heat sourceseparate from the pressurized gas.
 16. The method of claim 10, whereinthe metal sleeve comprises a plurality of circumferentially or helicallyextending slots.
 17. The method of claim 10, wherein the blood vessel isthe femoral artery of the patient.
 18. The method of claim 10, furthercomprising forming an outer polymer liner on the metal sleeve.